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Dobrodošli na strani podjetja AstraZeneca

To spletno stran lahko uporabite za prijavo neželenih dogodkov ali pritožb o kakovosti zdravil podjetij AstraZeneca, Alexion (podjetje družbe AstraZeneca za redke bolezni) in drugih podjetij AstraZeneca v skladu z obvestilom o zasebnosti, ki je vključeno na spletnih straneh družbe. Prav tako lahko pošljete medicinsko vprašanje za zgoraj omenjena zdravila.

Če poročate o neželenem dogodku/pritožbi o kakovosti izdelka, izberite državo, v kateri se je neželeni dogodek/pritožba o kakovosti izdelka zgodila, ne glede na vašo lokacijo.

S čim vam lahko pomagamo?

Izberite vse, kar ustreza

Neželeni dogodki so včasih znani kot neželeni učinki in so neželeni ali nepričakovani dogodki ali reakcije na zdravilo ali pripomoček.

Medicinsko vprašanje je zdravstveno ali znanstveno vprašanje v zvezi z našimi zdravili in pripomočki.

Pritožbe o kakovosti izdelkov se nanašajo na težavo z zdravilom ali pripomočkom in/ali njegovo embalažo.

Izberite možnost

Prijava neželenega dogodka

Neželeni dogodki so včasih znani kot neželeni učinki in so neželeni ali nepričakovani dogodki ali reakcije na zdravilo.

Pošljite medicinsko vprašanje

Medicinsko vprašanje je zdravstveno ali znanstveno vprašanje v zvezi z našimi zdravili in pripomočki.

Pritožba o kakovosti izdelka

Pritožbe o kakovosti izdelkov se nanašajo na težavo z zdravilom ali pripomočkom in/ali njegovo embalažo.

Kaj vas najbolje opisuje?

Jaz sem...

If you are a healthcare professional, you can access further information about AstraZeneca medicines and devices via https://azmedical.com.

(To možnost izberite samo, če ste prepričani, da se je neželeni dogodek zgodil v okviru programa sočutne uporabe zdravila družbe AstraZeneca (Early Access Program, EAP), programa sočutne uporabe za posameznega bolnika (Single Patient Early Access, SPEA), dostopa do zdravila po zaključenem kliničnem preskušanju (Post Trial Access, PTA) ali programa globalnega dostopa do zdravila (Global Access to Medicine, GATM)).

AstraZeneca Medical

Podatki o bolniku

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Identifikacijska številka programa, ki jo zagotavlja družba AstraZeneca. Za EAP in PTA je to lahko D-koda (ali druga koda, ki jo zagotovi družba AstraZeneca). Za SiPCU vnesite "SiPCU", za GATM vnesite "GATM". Če niste prepričani, se obrnite na kontaktno osebo družbe AstraZeneca.

Identifikacijska koda za določenega bolnika, ki je izkusil neželeni dogodek. Če niste prepričani, se obrnite na kontaktno osebo družbe AstraZeneca.

Kontaktni podatki

Demografski podatki

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Višina

Teža

Višina

Teža

Datum zadnje menstruacije
Datum poroda

Podatki o poročevalcu

Ali nas kontaktirate v imenu zdravstvenega delavca? Prosimo, izpolnite podatke o sebi.

Zdravstveni delavec

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Kontaktni podatki

Skrbnik

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Kontaktni podatki

Vaši podatki

Kaj najbolje opisuje vašo vlogo pri podjetju AstraZeneca?

Jaz sem...

Please enter your Patient Support Program or Market Research Program number here. For all other programs, please tick ‘Not applicable’

Datum prejetja poročila v AZ *

Ponudniki storitev za programe organiziranega zbiranja podatkov (ODCP) morajo v to polje vnesti identifikacijsko kodo (ID) bolnika ali referenčni ID ponudnika storitev. Prosimo, da jasno označite, kateri podatki so navedeni, ID bolnika ali referenčni ID ponudnika storitev, kot sledi: "Pat ID: [xxx]" ali "Ref ID: [yyy]". Prosimo zagotovite, da vnos ne presega 20 znakov. Dodatne informacije lahko vključite v polje za prosto besedilo (rubrika Povezava med zdravilom in dogodkom), pri tem zagotovite, da ne bodo vsebovale podatkov, ki omogočajo identifikacijo oseb.

Suppliers of Organized Data Collection Programs, such as Patient Support Programs, Market Research, Non-Interventional Studies, etc., are requested to fill in this field with either the Vendor Local Reference ID or Patient ID, and to clearly specify which data is being included. Use one of the following formats:

To enter only the Vendor Reference ID, write: "Ref ID: [yyy]"

To enter only the Patient ID, write: "Pat ID: [xxx]"

Warning: Make sure that the data entered does not exceed the 20-character limit.

If it is necessary to provide both identifiers, include them exclusively in the free text field located in the "Relationship between Medication and Event" section as follows:

"Pat ID: [xxx]; Ref ID: [yyy]"

Podatki o bolniku

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Identifikacijska številka programa, ki jo zagotavlja družba AstraZeneca. Za EAP in PTA je to lahko D-koda (ali druga koda, ki jo zagotovi družba AstraZeneca). Za SiPCU vnesite "SiPCU", za GATM vnesite "GATM". Če niste prepričani, se obrnite na kontaktno osebo družbe AstraZeneca.

Identifikacijska koda za določenega bolnika, ki je izkusil neželeni dogodek. Če niste prepričani, se obrnite na kontaktno osebo družbe AstraZeneca.

Kontaktni podatki

Demografski podatki

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Višina

Teža

Višina

Teža

Datum zadnje menstruacije
Datum poroda

Skrbnik

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Kontaktni podatki

Podatki o poročevalcu

Ali nas kontaktirate v imenu zdravstvenega delavca? Prosimo, izpolnite podatke o sebi.

Zdravstveni delavec

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Kontaktni podatki

Podatki o bolniku

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Identifikacijska številka programa, ki jo zagotavlja družba AstraZeneca. Za EAP in PTA je to lahko D-koda (ali druga koda, ki jo zagotovi družba AstraZeneca). Za SiPCU vnesite "SiPCU", za GATM vnesite "GATM". Če niste prepričani, se obrnite na kontaktno osebo družbe AstraZeneca.

Identifikacijska koda za določenega bolnika, ki je izkusil neželeni dogodek. Če niste prepričani, se obrnite na kontaktno osebo družbe AstraZeneca.

Kontaktni podatki

Demografski podatki

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Višina

Teža

Višina

Teža

Datum zadnje menstruacije
Datum poroda

Zdravnik

Podrobnosti o zdravniku

Kontaktni podatki zdravnika

Prosimo, navedite vsaj en kontaktni podatek

Zdravilo / Pripomoček z neželenim dogodkom

Prosimo, dodajte vsako zdravilo / pripomoček posebej z gumbom “Dodaj Zdravilo / Pripomoček”.

Rok uporabnosti

Please refer to the indications and usage described in the Japanese product information when entering the reason for taking the medication.

Datumi zdravljenja

Datum začetka

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Datum prenehanja

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Podrobnosti o cepljenju

1. odmerek

Rok uporabnosti

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Datum prejetja cepiva

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

1. odmerek

2. odmerek

Vaccination Facility

Additional Patient Information

Complete only for U.S military / Department of Defense (DoD) related reports

1. odmerek

2. odmerek

Informacije o dogodku

Prosimo, navedite posamezne neželene dogodke z gumbom "Dodaj dogodek".

Če informacije o poročanem neželenem dogodku presegajo dovoljeno število znakov, prosimo vključite preostale informacije v polje s prostim besedilom spodaj (Povezava med zdravilom in dogodkom).

Datumi tega dogodka

Datum začetka

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Datum prenehanja

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Trajanje dogodka
To polje je obvezno

Izberite ustrezne kriterije za ta dogodek

Izberite vse, kar ustreza, pustite prazno, če nič od navedenega ne ustreza

Pour les Collaborateurs AstraZeneca / Prestataires AstraZeneca:

sélectionner si applicable le ou les critère(s) de gravité tel que rapporté par le notificateur, sans interprétation de votre part.

Sélectionner tous les critères applicables (laisser vide si non applicable)

Lahko zahteva urgentno zdravljenje z zdravili ali kirurški poseg, da se prepreči smrt, invalidnost, prirojeno anomalijo ali okvaro pri rojstvu.

Podatki o smrti

Datum smrti

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Hospitalizacija

Datum sprejema

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Datum odpusta

Če točen datum ni znan, vnesite mesec in leto ali samo leto.

Povezava med zdravilom in dogodkom

Prosimo, navedite podrobnosti, če menite, da sta zdravilo / pripomoček in neželeni dogodek povezana.

Please change on the Product page if this is incorrect

Izberite možnost

Izberite možnost

Kateri neželeni dogodek je po vašem mnenju povezan s tem zdravilom/pripomočkom?*

Vaše medicinsko vprašanje

Odgovor želim do datuma

Pritožba o kakovosti izdelka

Rok uporabnosti

Hitre preiskave so namenjene izjemno resnim pritožbam o kakovosti izdelkov, ki lahko povzročijo tveganje za bolnike in/ali zahtevajo hitro obveščanje regulativnih organov.

Datum začetka napake

- Opišite naravo in podrobnosti pritožbe ter okoliščine, ki so privedle k odkritju.

- Kdaj in kako dolgo ste imeli težave z izdelkom?

- Ali je prišlo do napake v kakovosti pred, med ali po uporabi izdelka?

Če je vzorec na voljo, ga obdržite 21 dni od današnjega dne. Podjetje AstraZeneca lahko zahteva vzorec kot del naše preiskave.

Naslov, kamor bo poslana pošta z vrnjenim vzorcem

Pomagajte nam razumeti podrobnosti vaše pritožbe tako, da odgovorite na naslednja vprašanja*

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Device Appearance, Cosmetic damage

Device Appearance, Foreign Matter

Device Appearance, Plunger Rod, Stopper, Needle Guard, Syringe, Finger Flange, Needle Cover

Attachment/Detachment Issue Plunger Rod/Stopper

Attachment/Detachment Issue Syringe Plunger Rod back out

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Finger Flange

Attachment/Detachment Issue Needle Guard

B/M/D Plunger Rod

B/M/D Finger Flange

B/M/D Needle Guard

B/M/D Needle Cover

B/M/D Stopper

B/M/D Syringe

Device doesn’t function

Incorrect Dosing administered: Incorrect Dose

Incorrect Dosing administered: Incomplete dose

Device Label Missing/Damaged: Missing Label

Device Label Missing/Damaged: Unreadable Label

Device Label Missing/Damaged: Flawed Label

Device Label Missing/Damaged: Damaged Label

Fluid present after use

Fluid present during set up

Fluid present from a component: Needle Cover

Fluid present from a component: Syringe

Fluid present from a component: Stopper

Fluid present from a component: Unspecified

Device Missing Item/Needle Cover

Device Missing Item/Plunger Rod

Device Missing Item/Needle Guard

Device Missing Item/Finger Flange

Device Missing Item/Syringe

Needle Cover Damage

Needle Cover Difficult to Remove

Needle Clogged

Damaged Needle/Unspecified

Damaged Needle/Dull

Damaged Needle/Bent

Damaged Needle/Tip flat or not beveled

Damaged Needle/Needle detached/broke off

Damaged Needle/Needle missing

Needle Guard deployed early/ during carton opening

Needle Guard deployed early/ upon arrival

Needle Guard deployed early/removal from package

Needle Guard deployed early/removal of Needle Cover

Needle Guard deployed late

Needle Guard undeployed

Unable to administer/No dose

Unable to administer/No drug coming out

Pack Broken/Malformed/Damaged- Carton

Pack Broken/Malformed/Damaged- TES

Broken/Malformed/Damaged- Tray

Pack Broken/Malformed/Damaged- Carton Dirty

Foreign Matter in the packaging

Instructions Difficult to Understand

Literature Missing/Damaged: Missing Literature

Literature Missing/Damaged: Damaged Literature

Missing Text/IFU

Incorrect text/IFU

Missing Text/PI

Incorrect text/PI

Pack Artwork:Missing Text/Carton

Pack Artwork:Incorrect text/Carton

Missing Pack Item/APFS

Missing Pack Item/Tray

Pack Mix Up/Lot numbers

Pack Mix Up/Lliterature

Pack Printing/Flawed text

Pack Printing/missing text

Pack Printing/unreadable text

Product Appearance/Air Bubbles

Product Appearance/Cloudiness

Product Appearance/Discoloration

Consistency/Solubility

Foreign matter inside the syringe

Different/wrong looking APFS

Incorrect color of Plunger Rod

Incorrect color of Needle Guard

Incorrect color of Finger Flange

Different/wrong looking APFS

Different/wrong looking APFS

Different/wrong looking APFS

Odor/Taste/Drug

Odor/Taste/Package Components

Pack/Other

Medical/Adverse Event

Medical/Product Tag Alert

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Device Appearance, Cosmetic damage

Device Appearance, Foreign Matter

Device Appearance, Plunger Rod, Stopper, Needle Guard, Syringe, Finger Flange, Needle Cover

Attachment/Detachment Issue Plunger Rod/Stopper

Attachment/Detachment Issue Syringe Plunger Rod back out

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Finger Flange

Attachment/Detachment Issue Needle Guard

B/M/D Plunger Rod

B/M/D Finger Flange

B/M/D Needle Guard

B/M/D Needle Cover

B/M/D Stopper

B/M/D Syringe

Device doesn’t function

Incorrect Dosing administered: Incorrect Dose

Incorrect Dosing administered: Incomplete dose

Device Label Missing/Damaged: Missing Label

Device Label Missing/Damaged: Unreadable Label

Device Label Missing/Damaged: Flawed Label

Device Label Missing/Damaged: Damaged Label

Fluid present after use

Fluid present during set up

Fluid present from a component: Needle Cover

Fluid present from a component: Syringe

Fluid present from a component: Stopper

Fluid present from a component: Unspecified

Device Missing Item/Needle Cover

Device Missing Item/Plunger Rod

Device Missing Item/Needle Guard

Device Missing Item/Finger Flange

Device Missing Item/Syringe

Needle Cover Damage

Needle Cover Difficult to Remove

Needle Clogged

Damaged Needle/Unspecified

Damaged Needle/Dull

Damaged Needle/Bent

Damaged Needle/Tip flat or not beveled

Damaged Needle/Needle detached/broke off

Damaged Needle/Needle missing

Needle Guard deployed early/ during carton opening

Needle Guard deployed early/ upon arrival

Needle Guard deployed early/removal from package

Needle Guard deployed early/removal of Needle Cover

Needle Guard deployed late

Needle Guard undeployed

Unable to administer/No dose

Unable to administer/No drug coming out

Pack Broken/Malformed/Damaged- Carton

Pack Broken/Malformed/Damaged- TES

Broken/Malformed/Damaged- Tray

Pack Broken/Malformed/Damaged- Carton Dirty

Foreign Matter in the packaging

Instructions Difficult to Understand

Literature Missing/Damaged: Missing Literature

Literature Missing/Damaged: Damaged Literature

Missing Text/IFU

Incorrect text/IFU

Missing Text/PI

Incorrect text/PI

Pack Artwork:Missing Text/Carton

Pack Artwork:Incorrect text/Carton

Missing Pack Item/APFS

Missing Pack Item/Tray

Pack Mix Up/Lot numbers

Pack Mix Up/Lliterature

Pack Printing/Flawed text

Pack Printing/missing text

Pack Printing/unreadable text

Product Appearance/Air Bubbles

Product Appearance/Cloudiness

Product Appearance/Discoloration

Consistency/Solubility

Foreign matter inside the syringe

Different/wrong looking APFS

Incorrect color of Plunger Rod

Incorrect color of Needle Guard

Incorrect color of Finger Flange

Different/wrong looking APFS

Different/wrong looking APFS

Different/wrong looking APFS

Odor/Taste/Drug

Odor/Taste/Package Components

Pack/Other

Medical/Adverse Event

Medical/Product Tag Alert

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Hvala, ker ste nam pomagali bolje razumeti podrobnosti.

Podatke o napaki navedite v razdelku »Povejte nam o svoji pritožbi«.

What address can the PQC acknowledgement letter be sent to?

Če je poročevalec podal dovoljenje za kontakt, lahko družba AstraZeneca stopi v stik z njim in ga zaprosi za dodatne informacije prek šifriranega e-poštnega sporočila, poslanega prek orodja Mimecast.